ARCHITECT CA19-9XR REAGENT KIT

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS GENERATED ON THE ARCHITECT I2000SR PROCESSING MODULE FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED FOR SIDS (B)(6) FOR THE SAME PATIENT: (B)(6) 2024 INITIAL RESULT = 70.71 U/ML, SECOND TEST RESULT = 6.18 U/ML, THIRD TEST RESULT = 5.86 U/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

SECTION A1 PATIENT IDENTIFIER COMPLETE INFORMATION: (B)(6). THE COMPLAINT INVESTIGATION FOR FALSELY ELEVATED ARCHITECT CA 19-9XR RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND FIELD DATA REVIEW. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WAS REVIEWED. A REVIEW OF TRACKING AND TRENDING DID NOT IDENTIFY ANY TRENDS FOR THE COMPLAINT ISSUE. CUSTOMER FIELD DATA WAS USED TO ASSESS THE PERFORMANCE OF THE ARCHITECT CA 19-9XR ASSAY USING WORLDWIDE DATA. REVIEW SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 61047FP00 IS WITHIN ESTABLISHED LIMITS AND COMPARABLE WITH OTHER LOTS IN THE FIELD, CONFIRMING NO SYSTEMIC ISSUE FOR LOT 61047FP00. THE DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 61047FP00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT CA 19-9XR ASSAY FOR LOT NUMBER 61047FP00 WAS IDENTIFIED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2K91-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2K91-33 ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.